Respiratory patient interfaces

ABSTRACT

Various embodiments of respiratory patient interfaces that may be used to treat a variety of disorders involving upper airway obstruction, such as, without limitation, Obstructive sleep apnea (OSA), obstructive sleep hypopnea, and upper airway resistance syndrome (UARS). A number of the embodiments employ a nasal pillow assembly including a frame that supports a nasal pillow sleeve and a clip that is slid over a flange of the fame to couple the nasal pillow sleeve to the frame.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a Continuation of U.S. patent applicationSer. No. 13/060,113, filed Feb. 25, 2011, which claims benefit under 35U.S.C. §371 of International Application No. PCT/IB2009/053603 filed onAug. 15, 2009, which claims the priority benefit under 35 U.S.C. §119(e)of U.S. Provisional Application No. 61/091,551 filed on Aug. 25, 2008,the contents of which are herein incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to respiratory patient interfaces used todeliver a gas to a user, and in particular to various embodiments ofrespiratory patient interfaces that may be used to treat a variety ofdisorders involving upper airway obstruction.

2. Description of the Related Art

Obstructive sleep apnea (OSA), obstructive sleep hypopnea, and upperairway resistance syndrome (UARS) are among a variety of known disorderscharacterized by episodes of complete or partial upper airwayobstruction during a state of diminished consciousness, such as sleep,anesthetization, or post anesthesia. OSA, hypopnea, and UARS causeintermittent interruption of ventilation during sleep with theconsequence of potentially severe oxyhemoglobin desaturation. Typically,those afflicted with OSA, hypopnea, and UARS experience repeated,frequent arousal from sleep in response to the oxygen deprivation. Thearousals result in sleep fragmentation and poor sleep continuity.

Consequences of OSA, hypopnea, and UARS may include debilitating daytimesleepiness and cognitive dysfunction, systemic hypertension, cardiacdysrythmias, pulmonary arterial hypertension and congestive heartfailure. Other consequences may include a predisposition to myocardialinfarction, angina pectoris, stroke, right ventricular dysfunction withcor pulmonale, carbon dioxide retention during wakefulness as well asduring sleep, and continuous, reduced arterial oxygen tension. Moreover,the cognitive impairment resulting from OSA, hypopnea, and UARS putsthose afflicted at elevated risk of accidents.

The pathogenesis of the airway obstruction that characterizes OSA,hypopnea, and UARS can include both anatomic and functionalabnormalities of the upper airway that result in increased airflowresistance. Such abnormalities may include narrowing of the upper airwaydue to suction forces created during inspiration, the effect of gravitypulling the tongue back to appose the pharyngeal wall, and insufficientmuscle tone in the upper airway dilator muscles, among others. It isalso believed that excessive soft tissue in the anterior and lateralneck, as commonly observed in obese persons, can apply sufficientpressure to internal structures to narrow the upper airway and restrictair flow.

Conventional treatment of OSA, hypopnea, and UARS has included surgicalintervention, such as uvalopalotopharyngoplasty, gastric surgery forobesity, mandibular advancement procedures, maxillo-facialreconstruction, and tracheostomy. However, surgery potentially involvesconsiderable risk of post-operative morbidity and mortality. Inaddition, the failure rate of surgery is disturbingly high.Pharmacological therapy has also been proposed to treat OSA, hypopnea,and UARS; however, results have been generally disappointing.

More recently, various positive airway pressure therapies applied duringsleep have been used to treat OSA, hypopnea, and UARS patients. Duringsuch treatment, positive pressure is applied in the upper airway tosplint or support the airway open, thereby preventing its collapse andthe resultant airway obstruction. A typical positive airway pressuredevice comprises a flow generator (e.g., a blower) that delivers gas viaa delivery conduit to a patient interface, such as a mask or nasalpillow. It is also known to deliver the positive airway pressure therapyas a continuous positive airway pressure (CPAP), a variable airwaypressure, such as a bi-level pressure that varies with the patient'srespiratory cycle (Bi-PAP), or an auto-titrating pressure that varieswith the monitored condition of the patient. Pressure support therapiesare also provided to treat other medical and respiratory disorders, suchas Cheynes-Stokes respiration, congestive heart failure, and stroke.

Many patient interfaces are known in the art. These interfaces includenasal pillows with prongs which fit into the nares of the patient, nasalmasks which fit over the patient's nose, nasal-oral masks that fit overthe mouth and nose, and full face masks which fit over the patient'sentire face. It is known to maintain such interfaces on the face of apatient by a headgear that wraps around the head of the patient. Atypical headgear includes flexible, adjustable straps that extend fromthe nasal pillow and/or mask to attach it to the patient.

For such devices to be effective, two competing goals need to bebalanced: comfort and support. If the interface proves to beuncomfortable, patient compliance will be low. Comfort may be enhancedby reducing the area of contact between the interface and the patientand/or by using of a soft, lightweight, flexible material. In contrast,to enhance the ability of the interface to support its weight andassociated hoses and attachments, the interface should ideally beconstructed from a rigid material and have a large contact area betweenthe interface and the patient.

FIGS. 1 and 2 are isometric and exploded/disassembled views,respectively, of one prior art patient interface device 2 which attemptsto balance the competing goals of comfort and support. The patientinterface device 2 includes a headgear 4 and a nasal pillow assembly 6.The headgear 4 includes rigid or semi-rigid yokes 8 which providestability to the sides of the headgear 4. In addition, the headgear 4includes a headgear ring 9 having a seal ring 10 therein provided at theend of each yoke 8 for connecting the headgear to the nasal pillowassembly 6 as described below.

As seen most readily in FIG. 2, the nasal pillow assembly 6 includes aframe 12 made of a rigid material such as, without limitation, a plasticmaterial, which supports a pillow sleeve 14 made of a flexible materialsuch as, without limitation, silicone. The frame 12 includes a flangeportion 16 and connector portions 18 provided at each end of the frame12. The flange portion 16 includes vent holes 20 through which exhaledgasses may pass. The pillow sleeve 14 includes nasal prongs 22structured to be partial received within the nares of the patient.Finally, the nasal pillow assembly 6 includes a clip 24 made of a rigidmaterial such as, without limitation, a plastic material, the functionof which is described below.

The patient interface device 2 is assembled by first assembling thenasal pillow assembly 6 by wrapping the pillow sleeve 14 around theframe 12 in a manner such that each of the lipped ends 26 of the pillowsleeve 14 is received in a space formed between respective retainingflanges 28 and the flange 16. Then, the clip 24 is slid over the flange16 and the lipped ends 26 (FIG. 1). As seen in FIGS. 1 and 2, the clip24 includes a rectangular opening 30 which leaves the vent holes 20exposed when the nasal pillow assembly 6 is assembled. Next, theheadgear 4 is connected to the nasal pillow assembly 6 by inserting eachof the connector portions 18 of the frame 12 through a respective one ofthe headgear rings 9 and seals rings 10. Then, a cap 32 is inserted intoone of the connector portions 18 and a tube assembly 34 having an elbow36 is inserted into the other of the connector portions 18. Thepositions of the tube assembly 34 and the plug 32 may be interchangedaccording to preference, e.g., the typical sleeping position of thepatient. The tube assembly 34 is provided with a source of pressurizedgas.

Although the patient interface device 2 shown in FIGS. 1 and 2 may haveadvanced the art, there is still room for improvement in the field ofpatient interface devices. Described herein are a number of improvementsto patient interface devices such as, without limitation, the patientinterface device 2.

In addition, a prior version of the patient interface device 2 existswhich is similar in structure to the patient interface device 2. Themain difference between the two devices lies in the nasal pillowassembly of each. In particular, the nasal pillow assembly of the priorversion includes a pillow sleeve that is similar to the pillow sleeve 14of the patient interface device 2, except that it includes a series ofvent holes that are provided in front of the nasal prongs thereof. Inaddition, unlike the frame 12 and the clip 24 of the patient interfacedevice 2 which have one or more holes provided therein, the frame andclip of the prior version are both solid. Thus, in the prior version,exhaled gasses are passed through the vent holes of the pillow sleeverather then through the frame and clip. Patients using the prior versionoften switch to the patient interface device 2, which may lead tocertain problems relating component interchangeability as describedelsewhere herein. In particular, patients or caregivers may attempt touse components, such as the frame and clip of one version with theremaining components of the other version, which can be problematic.

SUMMARY OF THE INVENTION

In one embodiment, the present invention provides a patient interfacedevice that includes a frame for supporting a flexible interface memberthat is structured to deliver a gas to an airway of a patient, and aclip structured to be coupled to the frame by sliding the clip onto aflange provided as part of the frame. The flange includes a firstelement and the clip includes a second element, wherein one of the firstelement and the second element is structured to be received within theother of the first element and the second element when the clip is slidonto the flange to permit the clip to be fully slid onto the flange. Ifthe first and second elements do not mate in this manner, the clip willnot be able to be fully slid onto the flange. As a result, incompatibleclips are discouraged from being used with the frame.

In another embodiment, the invention provides a patient interface devicethat includes a frame having a flange extending along a longitudinalaxis of the frame, and an integrated interface assembly that includes aflexible interface member and a clip member affixed to the flexibleinterface member. The flexible interface member, such as a nasal pillowsleeve, is structured to deliver a gas to an airway of a patient. Theflexible interface member is also structured to be at least partiallywrapped around the frame and the clip member is structured to be snappedover the flange to couple the integrated interface assembly to theframe.

In yet another embodiment, the invention provides a patient interfacedevice that includes an interface assembly structured to deliver a gasto an airway of a patient, wherein the interface assembly has an endportion which defines an opening. The patient interface device alsoincludes an end cap having a post portion and an end portion. The postportion is received within the opening of the interface assembly and theend portion is structured to permit exhaled gases to flow therethrough.

In still another embodiment, the invention provides a patient interfacedevice that includes an interface assembly structured to deliver a gasto an airway of a patient and that includes an end portion which definesan opening. The patient interface device further includes a tubeassembly for delivering the gas to the interface assembly. The tubeassembly is coupled to the interface assembly through the openingtherein and includes an exhaust portion structured to permit exhaledgases to flow therethrough.

In yet another embodiment, the invention provides a patient interfacedevice that includes a nasal pillow assembly having a frame and aflexible pillow sleeve coupled to the frame. The nasal pillow assemblyis structured to deliver a gas to an airway of a patient. The patientinterface device also includes a headgear coupled to the nasal pillowassembly. The headgear includes a first side yoke coupled to a firstside of the frame and a second side yoke coupled to a second side of theframe. Also included is a first cheek stabilizer attached to an interiorof the first side yoke and a second cheek stabilizer attached to aninterior of the second side yoke.

In still a further embodiment of the invention, a patient interfacedevice is provided that includes a nasal pillow assembly having a frameand a flexible pillow sleeve coupled to the frame, wherein the nasalpillow assembly is structured to deliver a gas to an airway of apatient. The flexible pillow sleeve has a first nasal prong, a secondnasal prong, and a stabilizer provided between the first and secondnasal prongs. The stabilizer is structured to engage the patient's faceat a location above the patient's upper lip and below the patient'snose.

In still a further embodiment, the invention provides a patientinterface device that includes a flexible nasal pillow sleeve having afirst nasal prong and a second nasal prong for delivering a gas to anairway of a patient. The flexible nasal pillow sleeve includes at leastone integral stiffening member. In addition, the patient interfacedevice includes a first connecting portion attached to a first end ofthe flexible nasal pillow sleeve and a second connecting portionattached to a second end of the flexible nasal pillow sleeve. The firstconnecting portion and the second connecting portion are each structuredto receive either an end cap or a tube assembly therein. The devicefurther includes a headgear having a first yoke coupled to the firstconnecting portion and a second yoke coupled to the second connectingportion.

In another alternative embodiment, the invention provides a patientinterface device that includes a frame having a flange, a flexible nasalpillow sleeve supported by the frame that includes first and secondnasal prongs for delivering a gas to an airway of a patient, and a clipcoupled to the frame by sliding the clip over the flange. The clip, whenslid in this manner, couples the flexible nasal pillow to the frame. Thedevice also includes a chin support assembly coupled to the flexiblenasal pillow sleeve that is structured to support the patient's chin.

In yet another embodiment, the invention provides a patient interfacedevice that includes a nasal pillow sleeve having a first nasal prongand a second nasal prong for delivering a gas to an airway of a patient,a tube assembly operatively coupled to the nasal pillow sleeve fordelivering the gas to the nasal pillow sleeve, and a tube managementdevice having a first end and a second end. The first end of the tubemanagement device is coupled to the nasal pillow sleeve and ispositioned between the first and second nasal prongs, and the second endof the tube management device is coupled to and supports the tubeassembly. As a result, a majority of the tube assembly is positionedgenerally in a center of and below the nasal pillow sleeve when thedevice is worn by the patient.

Another embodiment provides a patient interface device that includes anasal pillow assembly structured to deliver a gas to an airway of apatient, wherein the nasal pillow assembly includes a frame having aflange, a flexible nasal pillow sleeve supported by the frame and havingfirst and second nasal prongs, and a clip coupled to the frame bysliding the clip over the flange. The device further includes an oralmember, such as a bite block, that is coupled to the nasal pillowassembly and that is structured to be received within the patient'smouth.

In yet another embodiment, the invention provides a patient interfacedevice that includes a nasal pillow assembly for delivering a gas to anairway of a patient, wherein the nasal pillow assembly includes acushion portion having first and second nasal prongs that is attached toa frame portion. The device further includes a tube assembly coupled tothe frame portion and in fluid communication with the nasal pillowassembly. The tube assembly is selectively slideable along the frameportion in a manner which maintains the fluid communication with thenasal pillow assembly in an airtight manner.

Therefore, it should now be apparent that the invention substantiallyachieves all the above aspects and advantages. Additional aspects andadvantages of the invention will be set forth in the description thatfollows, and in part will be obvious from the description, or may belearned by practice of the invention. Moreover, the aspects andadvantages of the invention may be realized and obtained by means of theinstrumentalities and combinations particularly pointed out in theappended claims.

The accompanying drawings illustrate presently preferred embodiments ofthe invention, and together with the general description given above andthe detailed description given below, serve to explain the principles ofthe invention. As shown throughout the drawings, like reference numeralsdesignate like or corresponding parts.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are isometric and exploded/disassembled views,respectively, of one particular prior art patient interface device;

FIG. 3 is a top plan view of a clip and FIG. 4 is a top plan view of aframe according to an embodiment of the invention;

FIG. 5 is a top plan view of a clip and FIGS. 6 and 7 are sideelevational and top plan views, respectively, of a frame according toanother embodiment of the invention;

FIG. 8 is an isometric view of a clip and FIG. 9 is an isometric view ofan integrated pillow sleeve assembly according to another embodiment ofthe invention;

FIG. 10 is a cross-sectional view of the clip of FIG. 9 coupled to theframe of FIG. 8;

FIG. 11 is an isometric view of an end cap according to one particularembodiment, and FIG. 12 is an isometric view of an end cap according toanother particular embodiment;

FIG. 13 is a side elevational view demonstrating airflow through the endcaps shown in FIGS. 11 and 12;

FIG. 14 is a side elevational view and FIG. 15 is an isometric view ofan end cap according to an alternative embodiment;

FIGS. 16-18 are isometric, front and rear views, respectively, of a gasdeflector according to a further embodiment of the invention, and FIG.19 is a side elevational view showing the gas deflector coupled to anend cap;

FIGS. 20A and 20B are isometric and side elevational views,respectively, of an end cap according to still a further embodiment ofthe invention;

FIGS. 21A and 21B are isometric and side elevational views,respectively, of an end cap according to yet a further alternativeembodiment of the invention;

FIG. 22 is an isometric view of a tube assembly according to a furtherembodiment of the invention;

FIG. 23 is an isometric view of a headgear according to yet anotheralternative embodiment;

FIG. 24 is a top plan view, and FIG. 25 is a side elevational view of apillow sleeve according to yet another embodiment of the invention;

FIGS. 26, 27 and 28 are front elevational views of various embodimentsof a bendable and formable pillow sleeve according to a further aspectof the invention;

FIG. 29 is a front elevational view and FIG. 30 is a side elevationalview of a patient interface device according to a further embodiment ofthe invention;

FIG. 31 is a front elevational view and FIG. 32 is a side elevationalview of a patient interface device according to yet another alternativeembodiment;

FIG. 33 is a side elevational view of a tube management device accordingto yet another embodiment of the invention;

FIG. 34 is a front elevational view of a patient interface device whichincorporates the tube management device shown in FIG. 33;

FIG. 35 is an isometric view of a patient interface device according toyet a further alternative embodiment of the invention;

FIG. 36 is an alternative embodiment of a patient interface device thatis similar to the patient interface device shown in FIG. 35;

FIG. 37 is an isometric view of yet a further alternative embodiment ofa patient interface device that includes an oral member;

FIG. 38 is a front elevational view of the patient interface deviceshown in FIG. 37 being worn by a patient;

FIG. 39 is an isometric view showing a nasal pillow assembly accordingto still a further embodiment;

FIG. 40 is an isometric view of a patient interface device according toyet a further alternative embodiment of the invention; and

FIGS. 41 and 42 shown one embodiment for implementing the sliding tubeassembly forming part of the patient interface device shown in FIG. 40.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Directional phrases used herein, such as, for example and withoutlimitation, top, bottom, left, right, upper, lower, front, back, andderivatives thereof, relate to the orientation of the elements shown inthe drawings and are not limiting upon the claims unless expresslyrecited therein.

As employed, herein, the statement that two or more parts or componentsare “coupled” together shall mean that the parts are joined or operatetogether either directly or through one or more intermediate parts orcomponents.

As employed herein, the statement that two or more parts or components“engage” one another shall mean that the parts exert a force against oneanother either directly or through one or more intermediate parts orcomponents.

As employed herein, the term “number” shall mean one or an integergreater than one (i.e., a plurality).

The present invention provides a number of modifications to patientinterface devices employing a nasal pillow such as the patient interfacedevice 2 shown in FIGS. 1 and 2 and/or the prior version thereofdescribed elsewhere herein. Such modifications and/or improvementsinclude modifications to certain of the components thereof and/orvariations of the patient interface device as a whole. The variousmodifications and/or improvements are described in detail below inconnection with FIGS. 3 through 42.

FIG. 3 is a top plan view of a clip 40 and FIG. 4 is a top plan view ofa frame 42 that may be used in connection with the patient interfacedevice 2 or a similar device as a substitute for the clip 24 and theframe 12. As seen in FIG. 4, the frame 42 includes connecting portions44 and a flange 46. The clip 40 is structured to be slid over the flange46 after a pillow sleeve such as, without limitation, the pillow sleeve14 is wrapped around the frame 42 in a manner similar to the mannerdescribed in connection with the patient interface device 2. As seen inFIG. 3, the clip 40 includes a plurality of vent holes 48 provided on atop face 50 thereof. In addition, the flange 46 of the frame 42 includesa generally rectangular shaped opening 52 therein. Thus, when a nasalpillow assembly is assembled using the frame 42, the clip 40 and apillow sleeve such as the pillow sleeve 14 shown in FIGS. 1 and 2,exhaled gasses may be vented through the vent holes 48 and the opening52. As will be appreciated, the clip 40 may suitably be used with thepillow sleeve 14 and the clip 12 having vent holes 20 provided thereinas shown in FIG. 2 and with the prior version of the patient interfacedevice 2 which includes a pillow sleeve having vent holes providedtherein and a solid frame.

FIG. 5 is a top plan view of a clip 54 which is structured to be used incombination with a frame 56 shown in FIGS. 6 and 7. In particular, asdescribed in more detail below, the clip 54 and the frame 56 areprovided with a mechanism that ensures that only the clip 54 may be usedwith the frame 56 so as to avoid a mismatch of components. As seen inFIG. 5, the clip 54 includes a generally rectangularly shaped opening 58provided on a front face 60 thereof. Alternatively, the opening 58 maybe replaced with a plurality of vent holes similar to the vent holes 48shown in FIG. 3. In addition, a first end 62 is provided with agenerally rectangularly shaped notch 64. Referring to FIGS. 6 and 7, theframe 56 includes connector portions 66 and a flange 68 having aplurality of vent holes 70 provided therein. Alternatively, the ventholes 70 may be replaced by a generally rectangularly shaped openingsimilar to the opening 52 shown in FIG. 4. In addition, the flange 68has a generally rectangularly shaped post 72 extending from a topsurface thereof. The shape of the post 72 is structured to match theshape of the notch 64. Thus, when the clip 54 is slid onto the flange 68after a pillow sleeve such as a pillow sleeve 14 has been wrapped aroundthe clip 56, the post 72 will be received within the notch 64 so thatthe clip 54 may be slid all the way in place on the frame 56. As will beappreciated, if a clip not having a notch 64 is attempted to be slidonto the frame 56, it will not be able to be slid completely thereon dueto interference provided by the post 72. As a result, the provision ofthe notch 64 and the post 72 ensure that only the clip 54 (or asimilarly structured clip) may be properly slid onto the flange 68during the assembly of a patient interface device that incorporates theframe 56, thereby preventing a mismatch of components (i.e., the use ofanother, non-matching clip).

FIG. 8 is an isometric view of a clip 74 structured to be used inconjunction with an integrated pillow sleeve assembly 76 as shown inFIG. 9. The frame 74 is similar to the frame 12 shown in FIGS. 1 and 2in that it includes connector portions 78 and a flange 80 having aplurality of vent holes 82 provided therein. One problem that isassociated with the frame 12 shown in FIGS. 1 and 2 is that a solidclip, such as the clip provided with the prior version of the patientinterface device 2 described elsewhere herein, may also be used incombination with the frame 12. This presents a potentially dangerouscondition because if the pillow sleeve 14, which does not include anyvent holes therein, is wrapped around the frame 12 and a prior solidclip is used instead of the clip 24 shown in FIGS. 1 and 2, theresulting assembly will not include any means for escape of exhalationgases as the solid clip will close and cover the vent holes 20 providedin the frame 12. Thus, when a pillow sleeve such as the pillow sleeve 14not having vent holes provided therein is intended to be used with aframe having vent holes provided therein, it is desirable to provide amechanism which prevents the improper use of a non-compatible clip suchas a solid clip therewith.

The use of such an improper clip is discouraged according to oneembodiment of the present invention by providing the integrated pillowsleeve member 76 shown in FIG. 9. In particular, the integrated pillowsleeve member 76 includes a pillow sleeve portion 79 which includesnasal prongs 80 and which is similar in structure to the pillow sleeve14 shown in FIGS. 1 and 2. However, the integrated pillow sleeve member76 also includes an integral clip member 82 that is provided as a partthereof. The integral clip member 82 may be affixed to the pillow sleeveportion 79 to form the integrated pillow sleeve member 76 in any of anumber of known manners. For example, and without limitation, the pillowsleeve portion 79 may be over molded onto the clip member 82, the pillowsleeve portion 79 may be affixed to the clip member 82 by an adhesive(such as a glue material), or the pillow sleeve portion 78 may beaffixed to the clip member 82 by a suitable mechanical attachmentmechanism. During assembly, the integrated pillow sleeve member 76 iswrapped around the frame 74 in a manner such that the clip member 82 isreceived between the upstanding end portions 84 of the clip 74 and issnapped over the flange 80 as shown in FIG. 10, which is across-sectional view showing the integrated pillow sleeve member 76 anda frame 74 assembled together. The clip member 82 of the integratedpillow sleeve member 76 includes a generally rectangular shaped opening86 which, in combination with the vent holes 82 of the frame 74, allowsexhaled gasses to escape from a patient interface device thatincorporates the assembly shown in FIG. 10. Because the clip 74 and theintegrated pillow sleeve member 76 requires the clip member 82 to besnapped over the flange 80 of the frame 74, users will not think aboutusing a sliding member in any patient interface device that includesthese components. Thus, as a result, it is unlikely that a user willmistakenly try to use a solid clip in any patient interface deviceintended to employ the clip 74. In addition, the upstanding end portions84 further discourage the use of a sliding clip with the frame 74. Inparticular, if the height of the upstanding end portions 84 is madelarge enough (larger than the height of the non-compatible clip), thenon-compatible clip will not be able to be slid over the flange 80 evenif a user were to attempt to do so. Furthermore, the ability to snap anon-compatible clip such as a solid clip over the flange 80 may belimited by making the dimension 88 shown in FIG. 10 larger than theinternal height of such an incompatible clip (as a result, even ifattempted, the clip will not be able to be snapped over the flange 80when a pillow sleeve such as pillow sleeve 14 is wrapped thereover). Asa result, any or all of these mechanisms help to ensure that only theintegrated pillow sleeve member 76 will be used in connection with theframe 74, thereby avoiding potentially dangerous combinations ofincompatible components. In addition, it would be undesirable andpotentially dangerous for the integrated pillow sleeve member 76 to beused with a solid frame as described elsewhere herein that does notinclude any vent holes or openings as such a combination would provideno means for exhaled gasses to escape. Therefore, it is desirable tomake the integrated pillow sleeve member 76 in a manner that woulddiscourage its use with such a frame. This may be done by making theinternal height of the clip member 82 small enough such that it cannotbe fit over the flange of the incompatible frame. The internal height isshown in FIG. 9 with reference numeral 90.

As described elsewhere herein, the patient interface device 2 shown inFIGS. 1 and 2 employs a cap 32 which is structured to be insertedthrough the headgear ring 9, the seal ring 10, and the connector portion18 when the patient interface device 2 is assembled. FIG. 11 is anisometric view of an end cap 92 according to one embodiment of thepresent invention. The end cap 92 includes a hollow post portion 94 thatis adapted to be received within a connector portion such as, withoutlimitation, a connector portion 18 of the patient interface device 2(and through the headgear ring 9 and seal ring 10 thereof). The end cap92 also includes an end portion 96 attached to the post portion 94. Theend portion 96 includes a plurality of vent holes 98 provided thereinwhich are in fluid communication with the interior of the post portion94. Thus, when the end cap 92 is inserted into a connector portion suchas the connector portion 18 of the patient interface device 2, patientexhaled gasses are able to vented through the vent holes 98. As will beappreciated, use of the end cap 92 allows the remaining portions of thepatient interface device with which it is used to be solid (i.e., do nothave any vent holes or openings therein). In particular, the end cap 92may be used with the pillow sleeve 14 shown in FIGS. 1 and 2 inconjunction with a solid frame and a solid clip (i.e., from the priorversion), because the end cap 92 provides the means through whichpatient exhaled gasses may escape. FIG. 12 is an isometric view of analternative end cap 100 according to an alternative embodiment of theinvention. The end cap 100 includes a hollow post portion 102 and an endportion 104. The end portion 104 is made at least partially from aporous material 106 that allows gasses to be passed from the interior ofthe post portion 102 through the end portion 104. The porous material ormedia 106 may be, for example, porous Polypropylene, porous High DensityPolyethylene (HDP), porous Ultra-High Molecular Weight Polyethylene(UHMWP), porous PTFE, porous PDDF, or other suitable porous materials.Example suitable materials are available from Porex Corporation ofFairburn, Ga. Any suitable porous membrane product will be acceptable.

FIG. 13 demonstrates the direction of flow of exhalation gasses wheneither the end cap 92 or the end cap 100 is employed in patientinterface device such as, without limitation, the patient interfacedevice 2.

FIG. 14 is a side elevational view and FIG. 15 is an isometric view ofan end cap 108 according to a further alternate embodiment of thepresent invention. The end cap 108 includes a hollow post portion 110and a bulbous end portion 112. The end portion 112 includes a pluralityof vent holes 114 that are in fluid communication with the interior ofthe post portion 110 in order to allow exhaled gasses to pass from theinterior of the end portion 110 through the vent holes 114. The bulbousnature of the end portion 112 provides for improved diffusion of gasflow as compared to the end portions 96 and 104 shown in FIGS. 11 and12. In particular, the flow of exhalation gasses, as shown in FIG. 14,is directed in a number of directions that intersects the longitudinalaxis of the post portion 110. In fact, in the embodiment shown in FIG.14, exhaled gasses are, as indicated by the arrows, able to flow in ahemispherical pattern over a span of more than 180 degrees with respectto the longitudinal axis of the end portion 110. This is in contrast tothe flow of exhaled gasses shown in FIG. 13, which flow is substantiallyparallel to the longitudinal axis of the post portion 94,102, as thecase may be. As a result, the flow of exhaled gasses when the end cap108 is employed is not as concentrated in a particular direction as inwhen end cap such as end cap 92 or 100 is used. Such a concentrated flowof exhaled gasses can, in some circumstances, be problematic as it maybe undesirably directed at, for example, the patient's ear or at the bedpartner of the patient.

FIGS. 16, 17 and 18 are isometric, front elevational, and rearelevational views of an embodiment of a gas deflector 116 according to afurther aspect of the present invention. As seen in FIG. 16-18, the gasdeflector 116 includes a deflector body 118, and legs 120 which define areceiving slot 122. As shown in FIG. 19, the gas deflector 116 isstructured to be mounted on an end cap such as end cap 92 or 100 inorder to advantageously deflect the exhaled gasses being emitted throughthe end cap 92,100 in a desired direction as indicated by the arrowsshown in FIG. 19. In particular, the end of the post portion 94,102 isstructured to be received within the receiving slot 122 of the gasdeflector 116. When so received, the legs 120 will be positioned betweenthe end portion 98,104 and the connecting portion of a frame in which itis inserted. The gas deflector 116 may be selectively positioned aboutthe outer periphery of the end cap 92,100 in order to cause thedeflector body 118 to selectively deflect the flow of gas in a desireddirection. As a result, the flow of gas may be selectively directed awayfrom a body part of the patient, such as the patient's ear, and/or thepatient's bed partner.

FIGS. 20A and 20B show an alternative end cap 124 according to analternative embodiment of the present invention. The alternative end cap124 includes a first portion 126 structured to be received within aconnecting portion of a frame, such as the connecting portion 118 of theframe 12 or any other connecting portion of a frame described elsewhereherein. A rotatable end portion 128 is rotatably attached to the postportion 126 in a manner which allows the end portion 128 to beselectively located relative to the longitudinal axis of the postportion 126 while maintaining an airtight seal between the end portion128 and the post portion 126. The end portion 128 is provided with aplurality of vent holes 130 along a selected, limited portion thereof.The vent holes 130 are in fluid communication with the interior of thepost portion 126 and allow exhaled gasses to flow from the interior ofthe post portion 126 through the vent holes 130. A user, by selectivelylocating the end portion 126, is able to selectively direct thedirection of flow of the exhaled gas as shown in FIG. 20B. In theembodiment shown in FIGS. 20A and 20B, the end portion 128 has agenerally cylindrical shape. FIGS. 21A and 21B show an alternativeembodiment of an end cap 124′ which is similar to the end cap 124 exceptthat the end portion 128′ of the end cap 124′ is generally dome shaped.Like the end portion 128, the end portion 128′ of the end cap 124′ isable to be selectively rotated in order to selectively direct the flowof exhaled gas as shown in FIG. 21B.

Referring to FIG. 22, an isometric view of a tube assembly 132 accordingto a further embodiment of the present invention is shown. The tubeassembly 132 includes a gas delivery tube 134, and elbow portion 136,and a post portion 138 which is adapted to be received within aconnecting portion of frame, such as the connecting portion 18 of theframe 12 or another connecting portion of a frame described elsewhereherein. As seen in FIG. 22, the elbow portion 136 of the tube assembly132 includes a plurality of vent holes 140. The vent holes 140 are influid communication with the interior of the post portion 138 and allowexhaled gasses to pass therethrough. As a result, as was the case withthe end caps 92,100,108,124 and 124′, the elbow portion 136 may be usedwith a pillow sleeve, a frame, and a clip that are solid and contain novent holes.

Referring to FIG. 23, a headgear 142 according to a further embodimentof the present invention is shown. The headgear 142 is similar to theheadgear 4 shown in FIGS. 1 and 2, except that it includes cheekstabilizers 144 on the interior of the yokes 146 thereof. Preferably,the cheek stabilizers 144 are in the form of a soft pad such as, withoutlimitation, a silicone gel or polyurethane gel pad. When the headgear142 is worn by a patient, the cheek stabilizers 144 are structured to bein contact with the patient's cheeks in order to stabilize the headgear142 in place and reduce the strapping forces that are necessary to holda nasal pillow assembly such as a nasal pillow assembly 6 or any othersuitable nasal pillow assembly as described herein in place. Preferably,as shown in FIG. 23, the cheek stabilizers 144 have a circular or oblongdisc shape.

FIG. 24 is a top plan view and FIG. 25 is a side elevational view of apillow sleeve 148 according to yet another embodiment of the presentinvention that may be used in connection with a frame and clip asdescribed herein, such as, without limitation, the frame 12 and the clip24 shown in FIGS. 1 and 2. The pillow sleeve 148 shown in FIGS. 24 and25 includes nasal prongs 150 and an upper lip stabilizer 152 providedbetween and below the nasal prongs 150. Preferably, the upper lipstabilizer comprises a soft pad made from, for example, a silicone gelor polyurethane gel material. Using either/or cheek stabilizers 144 andthe upper lip stabilizer 152 may allow the rigid portions of the yokes146 to be eliminated, thereby allowing the entire headgear 142 to bemade of a soft, flexible material. The upper lip stabilizer isstructured to be positioned beneath the nose and above the upper lipwhen an assembly employing the pillow sleeve 148 is worn.

FIGS. 26, 27 and 28 shows various embodiments of a pillow sleeve that isbendable and formable according to a further aspect of the invention.The pillow sleeves shown in FIGS. 26, 27 and 28 may be utilized withouta frame and a slide, such as the frame 12 and the slide 24. Inparticular, FIG. 26 shows a pillow sleeve 154 that includes nasal prongs156 and connecting portions 158 attached thereto. In addition, thepillow sleeve 154 further includes an integrated stiffening member 160that is preferably bendable and formable. The stiffening member may be,for example and without limitation, a metal or plastic material that isover molded with the pillow sleeve 154, attached to the pillow sleeve154 using a suitable adhesive, or inserted within a pocket provided inthe pillow sleeve 154. The connecting portions 158 are preferably madeof a rigid material and may be over molded with the pillow sleeve 154,attached to the pillow sleeve 154 with a suitable adhesive, or otherwiseattached to the pillow sleeve 154 using a suitable mechanical attachmentmechanism. The connecting portions 158 are structured to be able toreceive any one of the end caps 32,92,100,124 or 124′. In addition, theconnecting portions 158 are also structured to be able to receive thetube assembly 34 or the tube assembly 132 shown in FIG. 22. Thestiffening member 160, in addition to providing sufficient rigidity toeliminate the need for a frame and a slide, also makes the nasal pillow154 bendable and formable so as to be able to custom adjust the angle ofthe nasal prongs 156. FIG. 27 is an alternate embodiment of a pillowsleeve 154 that includes a vertically oriented stiffening member 160,and FIG. 28 is an embodiment of a pillow sleeve 154″ that includesmultiple stiffening members 160.

FIG. 29 is a front elevational view and FIG. 30 is a side elevationalview a patient interface device 162 according to a further embodiment ofthe invention. The patient interface device 162 includes, in theparticular embodiment shown, a nasal pillow assembly 164 that is similarto the nasal pillow assembly 6 shown in FIGS. 1 and 2. The nasal pillowassembly 164 includes a pillow sleeve 166 having nasal prongs 168, aframe 170, and a clip 172. Although a frame 170 and a clip 172 similarto the frame 12 and clip 24 shown in FIGS. 1 and 2 are shown in thisparticular embodiment, it should be understood that this is not meant tobe limiting and that other frames and/or clips as described elsewhereherein may be used as desired. A tube assembly 174 is inserted within aconnecting portion 176 of the frame 170 and an end cap 178 is insertedwithin the other connecting portion 176 of the frame 170. The end cap178 may either similar to the end cap 32 shown in FIGS. 1 and 2, or anyof the end caps 92,100,108,124 or 124′. In addition, the patientinterface device 162 includes a chin support assembly 180 including arigid body having arms 182. A chin support strap 184 is inserted througha pair of apertures 186 for supporting the chin of the patient, and aheadgear strap 188 is inserted through apertures 190 and is structuredto wrap around the head of the patient to help support the patientinterface device 162. The nasal pillow assembly 164 is attached to thechin support assembly 180 by way of a rigid connector 192. Preferably,the rigid connector is molded as part of the body of the chin supportassembly 180 and is attached to the pillow sleeve 166 of the nasalpillow assembly 164 using a suitable mechanism, such as over molding, anadhesive, or some other mechanical attachment mechanism. As seen inFIGS. 29 and 30, gas is delivered to the patient interface device 162through the tube assembly 174 in a manner similar to the manner in whichgas is delivered to the patient interface device 2 through the tubeassembly 34 shown in FIGS. 1 and 2. In an alternative embodiment, thechin support strap 184 may be replaced by a rigid chin support memberthat forms a part of the chin support assembly 180.

FIG. 31 is a front elevational view and FIG. 32 is a side elevationalview of a patient interface device 162′ that is similar to the patientinterface device 162 shown in FIGS. 31 and 32, except that instead ofgas being delivered thereto by way of a tube assembly 174 that issimilar to the tube assembly 34, gas is delivered thereto by a tubeassembly 194 that includes a rigid main tube and support mechanism 196that is connected to a main supply tube 198, and a tube assembly branch200 which is in fluid communication with the main tube and supportmechanism 196 at one end thereof and the nasal pillow assembly 164 atthe opposite end thereof. As seen in FIG. 32, in this embodiment of thepatient interface device 162′, arms 182 extend from the main tube andsupport mechanism 196.

As noted elsewhere herein, when a patient assembles the patientinterface device 2 shown in FIGS. 1 and 2, the patient must decide onwhich side to place the tube assembly 34. Typically, the patient usesone side or the other depending upon which side of the body the userprefers to sleep on. As will be appreciated, once the user makes thischoice and places the patient interface device 2 on his or her head, theuser's ability to sleep on the other side of his or her body is limited(the tube assembly 34 will get in the way if the user switches tosleeping on the other side). FIG. 33 is a side elevational view of atube management device in the form of an S-shaped hook 202 which enablesa patient to simply and easily position the tube assembly 34 in thecenter of his or her body. The hook 202 includes a first end 204 and asecond end 206. Preferably, the hook 202 is made from a rigid orsemi-rigid material such as, without limitation, metal or plastic. Asseen in FIG. 34, the user hooks the first end 204 around the center ofthe nasal pillow assembly 6 in between the nasal prongs 22. The userthen positions the tube assembly 34 so that it is supported by thesecond end 206 of the hook 202. As seen in FIG. 34, this will result inthe majority of the tube assembly 34 being positioned generally in thecenter of and below the patient interface device 2 and therefore in thecenter of the patient's body when the patient interface device 2 is wornby the patient. As shown by the arrows in FIG. 34, the hook 202 may beselectively slid from side-to-side on the nasal pillow assembly 6 inorder to selectively position the hook 202 and therefore the tubeassembly 34. Furthermore, although the hook 202 has been demonstrated inconnection with the patient interface device 2, it should be understoodthat this is meant to be exemplary only, and not limiting, and that thehook 202 may be used in connection with other patient interface deviceembodiments such as the various embodiments described elsewhere herein.

FIG. 35 is an isometric view of a patient interface device 208 accordingto a further alternative embodiment of the present invention. Thepatient interface device 208 includes a nasal pillow assembly 210 thatis similar to the nasal pillow assembly 6 shown in FIGS. 1 and 2. Thenasal pillow assembly 210 includes a pillow sleeve 212 having nasalprongs 214. The nasal pillow assembly 210 also includes a frame 216 anda clip 218 that are similar to the frame 12 and clip 24 shown in FIGS. 1and 2. A tube assembly 220 is attached to one side of the nasal pillowassembly 210, and an end cap 222 is attached to the opposite side of thenasal pillow assembly 210. The nasal pillow assembly 210 is supported bya chin support assembly 224 that includes arms 226, chin support strap228 and headgear strap 230. The patient interface device 208 furtherincludes an oral member 232, which in the particular embodiment shown inFIG. 35 comprises a bite block inserted within the patient's mouth andheld between the patient's teeth. The oral member 232 is attached to thechin support assembly 224 through a connecting member 234 which may berigid or flexible. The oral member 232 provides additional stability tothe patient interface device 208 when worn by the patient. Theconnecting member 224 may, in one embodiment, comprise a gas flowpassage that is in fluid communication with the nasal pillow assembly 6in order to receive gas therefrom. In such an embodiment, the oralmember 232 would include an opening to allow the supplied gas to enterthe patient's mouth and thereafter the patient's airway.

FIG. 36 is an alternate embodiment of a patient interface device 208′that is similar to the patient interface device 208 except that itincludes a tube assembly 194 that is shown in FIG. 31 for the deliveryof the gas to the nasal pillow assembly 210. Furthermore, although anasal pillow assembly 210 that is similar to the nasal pillow assembly 6is shown in FIGS. 35 and 36, it should be understood that this is meantto be exemplary only, and not limiting, and that other nasal pillowassemblies such as those shown elsewhere herein may be employed. FIG. 37shows a further alternative embodiment of a patient interface device 236that includes an oral member 232 as shown in FIGS. 35 and 36 but doesnot include the chin support mechanism 224. Instead, as shown in FIG.37, headgear 4 having yokes 8 is provided (for ease of illustration,only one yoke 8 is shown in FIG. 37). Again, the oral member 232provides added stability for the patient interface device 236. FIG. 38is a front view of the patient interface device 236 shown being worn bya patient. As seen in FIG. 38, the nasal prongs 214 are received withinthe patient's nose and the oral member 232 is received within thepatient's mouth. In addition, as shown in FIG. 38, the connecting member234 is adapted to be bent in order to be selectively positioned for acomfortable fit.

Patients which use patient interface devices such as, withoutlimitation, the patient interface device 2 shown in FIGS. 1 and 2 oftenhave different sized noses. As a result, different sized nasal prongswill be better suited for a particular patient depending upon the sizeof the patient's nose. Patient interface device 2 is often provided,therefore, with multiple pillow sleeves 14 having differing size nasalprongs 22 so that the appropriate pillow sleeve 14 can be selected bythe patient. However, changing pillow sleeves 14 requires completedisassembly of the nasal pillow assembly 6, which can be time consumingand inconvenient. FIG. 39 shows a pillow sleeve assembly 238 accordingto another embodiment of the invention which addresses this problem. Thepillow sleeve assembly 238 includes a pillow sleeve 240 having openings242 provided therein which are adapted to receive and hold removablenasal prongs 244 of various different sizes. Thus, a patient is able toselect the proper size nasal prongs 244 without the need to completelydisassemble a nasal pillow assembly that includes the pillow sleeveassembly 238.

FIG. 40 is an isometric view of a patient interface device 246 accordingto yet a further alternative embodiment of the invention. The patientinterface device 246 includes a nasal pillow assembly 248 that includesa cushion portion 250 made of a flexible material such as, withoutlimitation, silicone, having nasal prongs 252 extending therefrom.Cushion portion 250 is attached to rigid frame portion 254 by, forexample, over molding the two pieces together, adhering the two piecestogether using a suitable adhesive, or attaching the two pieces togetherusing any suitable mechanical attachment mechanism. Support frameportion 254 is made of a suitable rigid material, such as, withoutlimitation, plastic. Support frame portion 254 includes connectorportions 256 structured to be attached to straps 258 of a headgearforming a part of the patient interface device 246. Furthermore, thepatient interface device 246 includes a tube assembly 260 that isconnected to a source of pressurized gas. The tube assembly 260 includesa main conduit 262, an elbow portion 264 and a connecting portion 266.As shown by the arrows in FIG. 40, the main conduit 262 is structured tobe able to rotate relative to the elbow portion 264, the elbow portion264 is structured to be able to independently rotate relative to theconnecting portion 266, and the tube assembly 260 in its entirety isstructured to be slideable along the support frame portion 254 in orderto selectively position the tube assembly 260 relative to the front ofthe nasal pillow assembly 248.

FIGS. 41 and 42 show one embodiment for implementing the sliding tubeassembly 260 shown in FIG. 40. In particular, a sliding mount 268 isprovided within the nasal pillow assembly 248 in sliding engagement withthe support frame 254. In addition, the sliding mount engages thesupport frame portion 254 in a manner which maintains an airtight seal.The sliding mount includes the connecting portion 266 in the form of asnap-on connector mount which is adapted to have snap fit thereon theelbow portion 264 in a manner which provides an airtight seal. Inaddition, a slideable sealing mechanism having a plurality ofinterconnected slide elements 272 is provided within an aperture 274provided in the support frame 254 which enables the tube assembly 260 tobe slid along the aperture 274 while at the same time maintaining anairtight seal and connection between the tube assembly 260 and the nasalpillow assembly 248. The patient interface device 246, by providing formultiple degrees of selective movement of the tube assembly 260,including the ability to slide and selectively position the tubeassembly along the front face of the nasal pillow assembly 248, providesfor added comfort and convenience for the patient.

While preferred embodiments of the invention have been described andillustrated above, it should be understood that these are exemplary ofthe invention and are not to be considered as limiting. Additions,deletions, substitutions, and other modifications can be made withoutdeparting from the spirit or scope of the present invention.Accordingly, the invention is not to be considered as limited by theforegoing description but is only limited by the scope of the appendedclaims.

1. A patient interface device, comprising: an interface assemblystructured to deliver a gas to an airway of a patient, said interfaceassembly having an elongated axis and an end portion defining an openingat one end of the elongated axis; and a tube assembly for deliveringsaid gas to said interface assembly, said tube assembly being coupled tosaid interface assembly though said opening and including an exhaustportion structured to permit exhaled gasses to flow therethrough to theambient atmosphere.
 2. The interface device according to claim 1,wherein said exhaust portion includes a plurality of vent holes.
 3. Theinterface device according to claim 2, wherein said tube assemblyincludes a post portion received within said opening, an elbow portionand a delivery tube, said elbow portion comprising said exhaust portion.4. A patient interface device, comprising: a nasal pillow assemblyhaving a frame and a flexible pillow sleeve coupled to said frame, saidnasal pillow assembly being structured to deliver gas to an airway of apatient; a headgear coupled to said nasal pillow assembly, said headgearhaving a first side yoke coupled to a first side of said frame and asecond side yoke coupled to a second side of said frame; and a firstcheek stabilizer attached to an interior of said first side yoke and asecond cheek stabilizer attached to an interior of said second sideyoke.
 5. The patient interface device according to claim 4, wherein saidfirst cheek stabilizer and said second cheek stabilizer each comprise agel pad.
 6. The patient interface device according to claim 5, whereinthe gel pad is one of a silicone gel pad and a polyurethane gel pad. 7.The patient interface device according to claim 4, wherein said firstcheek stabilizer and said second cheek stabilizer each have either acircular or oblong disc shape.
 8. A patient interface device,comprising: a nasal pillow assembly having a frame and a flexible pillowsleeve coupled to said frame, said nasal pillow assembly beingstructured to deliver a gas to an airway of a patient, said flexiblepillow sleeve having a first nasal prong, a second nasal prong, and astabilizer provided between said first nasal prong and said second nasalprong, said stabilizer being structured to engage said patient's face ata location above said patient's upper lip and below said patient's nose.9. The patient interface device according to claim 8, wherein saidstabilizer is provided below said first nasal prong and said secondnasal prong.
 10. The patient interface device according to claim 9,wherein said stabilizer comprises a gel pad.
 11. The patient interfacedevice according to claim 10, wherein the gel pad is one of a siliconegel pad and a polyurethane gel pad.